Application 020288

Type: NDA
Sponsor: MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MONISTAT 7 COMBINATION PACK	MICONAZOLE NITRATE	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	2%,100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020288-002	MONISTAT 7 COMBINATION PACK	MICONAZOLE NITRATE	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL		RLD, RS	1993-04-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Monistat 7 with Reusable Applicator	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	2aad40f2-4eea-441d-8b34-5613f1955405	2025-10-27	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Monistat 3 3 Day	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5	2025-10-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
CareOne Miconazole 3	MICONAZOLE NITRATE	American Sales Company	84c43793-98e4-4e68-a3bc-3e7222135568	2025-10-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3	MICONAZOLE NITRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	689ad530-48f9-4044-baa3-4f8b0657aeef	2025-10-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Leader Miconazole 3	MICONAZOLE NITRATE	Cardinal Health 110, LLC. dba Leader	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2025-09-29	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Equate Miconazole 3	MICONAZOLE NITRATE	WALMART INC.	5ade4c65-5757-4f20-b5be-f95d86363d11	2025-09-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Equaline Miconazole 3	MICONAZOLE NITRATE	United Natural Foods, Inc. dba UNFI	89328324-72d9-4b3d-bec7-cc2e4e62f034	2025-09-18	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 3 day	MICONAZOLE NITRATE	Publix Super Markets Inc	9ff23f06-e97f-46ad-8601-97ca05c260a0	2025-09-16	Warnings	Name fallback generic name: MICONAZOLE NITRATE
topcare miconazole 3 combination pack	MICONAZOLE NITRATE	Topco Associates LLC	0af4c06a-aa79-48ab-9857-e0f56317d8f3	2025-09-16	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 3	MICONAZOLE NITRATE	Meijer Distribution Inc	feaa0d07-013e-433f-8db4-550dc9ff737e	2025-09-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	89132802-beb1-42f4-8da4-39918fc5c4dd	2025-09-09	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3 Combination Pack	MICONAZOLE NITRATE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	50f2a26c-8203-4a10-8d0d-ad0f9fadb6bc	2025-09-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3 Combination Pack	MICONAZOLE NITRATE	Chain Drug Consortium, LLC	d01f7ef9-4f04-4874-a625-0335f6392b73	2025-09-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Cream	MICONAZOLE NITRATE	Encube Ethicals, Inc.	8be4bbfa-424c-4ccf-b8bc-65b16c126053	2025-09-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Femmesil Maximum Strength	MICONAZOLE NITRATE	Aidance Skincare & Topical Solutions, LLC	d8b01fe1-4465-497b-909e-f51f31fdf833	2025-08-25	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Nedtol Folliculitis Treatment Creams	MICONAZOLE NITRATE	Jiashen International Trade Limited	3d0a1e39-82e4-9337-e063-6294a90aa9a3	2025-08-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Monistat 7 Combination Pack 7-Day Pre-Filled Applicators	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	9b1ac735-9b18-48c2-86dc-93d07157d5e5	2025-08-22	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Foster and Thrive Miconazole 3	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	ba5d5b13-5604-4b8c-92b9-9f4174458029	2025-08-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti- Fungal Miconazole Nitrate	MICONAZOLE NITRATE	Premier Brands of America Inc.	f186bdc1-db6c-0fab-e053-2995a90a7c58	2025-08-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	cca84334-2e2d-4991-9d1e-d5b7c9ffd392	2025-08-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.